Low profile occlusion balloon catheter

ABSTRACT

A low profile occlusion catheter having a guiding atraumatic tip that prevents entry of the balloon into collateral vessels. The occlusion catheter system is particularly well suited for use in vascular occlusion and includes a pressure monitoring line to monitor the degree and state of occlusion.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/917,286, filed Mar. 8, 2016 and titled, “Low ProfileOcclusion Catheter, which is a national stage application under 35U.S.C. § 371 of International Patent Application No. PCT/US2014/054802,filed Sep. 9, 2014 and titled, “Low-Profile Balloon Occlusion Catheter,”which was published under International Publication No. WO 2015/035393A1 and claims the benefit of U.S. Provisional Patent Application Nos.62/010,275, filed on Jun. 10, 2014 and 61/875,498, filed Sep. 9, 2013,both titled, “Low-Profile Balloon Catheter,” each of the disclosures ofwhich are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

This invention was made with government support under Contract No.W81XWH-12-1-0558 awarded by U.S. Army Medical Research Materiel Command.The government has certain rights in the invention.

BACKGROUND

The invention generally relates to percutaneously introduced occlusioncatheters, and more particularly to an occlusion catheter having anatraumatic guiding tip formed of an elastomeric polymer. Moreparticularly, the present invention pertains to an occlusion catheter inwhich the atraumatic guiding tip is formed of entirely of polymer,polymer reinforced with a shape memory or superelastic material, orentirely of a shape memory or superelastic material. Still moreparticularly, the present invention pertains to an occlusion catheterhaving at least one lumen suitably configured to introduce or withdrawbody fluids from a patient into which the catheter is placed, and/or forsensing a condition within the body, such as, for example, pressure orflow rate in the region of the catheter. Yet still more particularly,the present invention pertains to an occlusion catheter having a firstcatheter member with a first lumen extending longitudinally through thefirst catheter member and open at a distal end of the first cathetermember; a second catheter member having a second lumen extendinglongitudinally through the second catheter member and open at a distalend of the second catheter member, the second catheter member ispositioned over and in spaced apart relationship relative to a proximalsection of the first catheter member forming an annular space betweenthe second catheter member and the first catheter member, the proximalsection of the first catheter member resides within the second lumen ofthe second catheter member and the first catheter member extends beyondthe distal end of the second catheter member, a third catheter memberhaving a third lumen extending longitudinally through the third cathetermember and open at a distal end of the third catheter member; the thirdcatheter member is positioned over a distal section of the firstcatheter member, the third catheter member having a distal section thatextends distally from a distal end of the first catheter member suchthat the first lumen and the third lumen are in fluid flowcommunication, whereby the second and third catheter are spaced apartfrom each other along a longitudinal axis of the first catheter memberwith the first catheter member extending there between; the atraumaticguiding tip member being joined to a distal end of the third cathetermember; and an expandable member, such as a balloon, coupled to thesecond catheter member and to the third catheter member, such that thespace between the second catheter member and the third catheter memberis within an area bounded by the expandable member.

Balloon catheters generally comprise an elongated catheter shaft with anexpandable balloon on the distal end of the shaft, and are used in anumber of different medical procedures, including, for example,angioplasty, stent placement, occlusion, drug deliver, etc. The catheteris introduced through a percutaneous introducer sheath and maneuveredinto the patient's blood vessels until the balloon is properlypositioned within the body, such as at the stenotic site to be dilatedor at a site requiring occlusion, drug delivery or other procedure suchas stent placement.

It is often desirable for balloon catheters to have very low profiles inorder to facilitate passage of the balloon across severe and remotevascular obstructions. High strength materials are commonly required inthe design of balloon catheter components to prevent shaft buckling whenthe balloon is inflated. Additionally, high strength materials arerequired so that torque applied to the proximal end of the catheterresults in rotation of the distal tip of the catheter. High flexibilitymaterials are also commonly required in the design of balloon cathetercomponents to maintain a low-profile and avoid trauma or perforation ofthe blood vessels while the catheter is maneuvered through the patient'stortuous vasculature.

Conventional balloon catheters, particularly those intended for vascularocclusion, do not adequately balance the need for proximal segmentstiffness with the need for low profile, flexible distal segment andtrack ability through the tortious vascular pathway without entry intocollateral vessels. Therefore, a need exists for a low profile occlusioncatheter with a high strength and relatively stiff proximal segment anda flexible distal segment with an atraumatic tip having a design thatpermits tracking along the major vessels while preventing entry intocollateral vessels.

SUMMARY OF THE INVENTION

Described herein are systems, methods and compositions for an occlusioncatheter system comprising: a first catheter member having a first lumenextending longitudinally through the first catheter member and open at adistal end of the first catheter member; a second catheter member havinga second lumen extending longitudinally through the second cathetermember and open at a distal end of the second catheter member, thesecond catheter member is positioned over and in spaced apartrelationship relative to a proximal section of the first catheter memberforming an annular space between the second catheter member and thefirst catheter member, the proximal section of the first catheter memberresides within the second lumen of the second catheter member and thefirst catheter member extends beyond the distal end of the secondcatheter member, a third catheter member having a third lumen extendinglongitudinally through the third catheter member and open at a distalend of the third catheter member; the third catheter member ispositioned over a distal section of the first catheter member, the thirdcatheter member having a distal section that extends distally from adistal end of the first catheter member such that the first lumen andthe third lumen are in fluid flow communication, whereby the second andthird catheter are spaced apart from each other along a longitudinalaxis of the first catheter member with the first catheter memberextending there between; an atraumatic tip member having a proximalsection co-axially coupled to a distal end of the third catheter memberand terminating the third lumen in the third catheter member; and anexpandable occlusion member, such as a balloon, coupled at its proximalend to the second catheter member and at its distal end to the thirdcatheter member and in fluid flow communication with the second lumen ofthe second catheter member, the expandable occlusion member beingpositioned such that the longitudinal space between the second cathetermember and the third catheter member is within the expandable occlusionmember.

Also disclosed herein are systems, methods and compositions forocclusion catheter system comprising: a first catheter member having afirst and second lumens extending along a longitudinal axis thereof thatforms a proximal section of the catheter system, a second cathetermember having a third lumen forming a distal section of the cathetersystem and coupled to a distal end of the first catheter member, anexpandable occlusion balloon coupled at its proximal end to a distal endof the first catheter member and at its distal end to a proximal end ofthe second catheter member, a first lumen of the first catheter memberterminating within the expandable occlusion balloon to communicate aninflation fluid to an area within the expandable occlusion balloon and asecond lumen of the first catheter member being in fluid flowcommunication with the third lumen of the second catheter member, anatraumatic guiding tip coupled to a distal end of the third lumen of thesecond catheter member; and a third catheter member having at least onelumen passing longitudinally there through, the third catheter memberbeing disposed within each of the second lumen of the first cathetermember and the third lumen of the second catheter member and passingthere through.

The methods, systems, and apparatuses are set forth in part in thedescription which follows, and in part will be apparent from thedescription, or can be learned by practice of the methods, apparatuses,and systems. The advantages of the methods, apparatuses, and systemswill be realized and attained by means of the elements and combinationsparticularly pointed out in the appended claims. It is to be understoodthat both the foregoing general description and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the methods, apparatuses, and systems, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying figures, like elements are identified by likereference numerals among the several preferred embodiments of thepresent invention.

FIG. 1 is a perspective view of an embodiment of a occlusion catheterdescribed herein.

FIG. 2 is an enlarged perspective view of the first port of theinventive occlusion catheter depicted in FIG. 1.

FIG. 3 is a longitudinal cross-sectional view of FIG. 2.

FIG. 4 is a perspective view of a distal section of the inventiveocclusion catheter depicted in FIG. 1

FIG. 5 is a perspective longitudinal cross-sectional view taken alongline 5-5 of FIG. 4.

FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 1.

FIG. 7 is a partial cross-sectional end view of a proximal hub of theocclusion catheter of the present invention.

FIG. 8 is a transverse cross-sectional view taken along line 8-8 of FIG.1 and line 8-8 of FIG. 6.

FIG. 9 is a perspective view of an alternative embodiment of theinventive occlusion catheter.

FIG. 9A is a cross-sectional view taken along line 9A-9A of FIG. 9.

FIG. 9B is a partial cross-sectional end view of FIG. 9.

FIG. 9C is a cross-sectional view taken along line 9C-9C of FIG. 9

FIG. 9D is a cross-sectional view taken along line 9D-9D of FIG. 9.

FIG. 10 is a perspective view of another alternative embodiment of theinventive occlusion catheter depicting an alternative embodiment of aguiding atraumatic tip.

FIG. 11 is an enlarged perspective view of the alternative embodiment ofthe guiding alternative tip of FIG. 10.

FIG. 12 is a perspective view of another embodiment of a occlusioncatheter described herein.

FIG. 13 is an enlarged perspective view of the first port of theinventive occlusion catheter depicted in FIG. 12.

FIG. 14 is a longitudinal cross-sectional view of FIG. 13.

FIG. 15 is a perspective view of a distal section of the inventiveocclusion catheter depicted in FIG. 12

FIG. 16 is a perspective longitudinal cross-sectional view taken alongline 16-16 of FIG. 15.

FIG. 17 is a cross-sectional view taken along line 17-17 of FIG. 12.

FIG. 18 is a transverse cross-sectional view taken along line 18-18 ofFIG. 1 and line 18-18 of FIG. 6.

DETAILED DESCRIPTION OF THE INVENTION

The foregoing and other features and advantages of the invention willbecome more apparent from the following detailed description ofexemplary embodiments, read in conjunction with the accompanyingdrawings. The detailed description and drawings are merely illustrativeof the invention rather than limiting, the scope of the invention beingdefined by the appended claims and equivalents thereof.

While the invention has been described in connection with variousembodiments, it will be understood that the invention is capable offurther modifications. This application is intended to cover anyvariations, uses or adaptations of the invention following, in general,the principles of the invention, and including such departures from thepresent disclosure as, within the known and customary practice withinthe art to which the invention pertains.

Furthermore, while the invention is described as an occlusion cathetersystem, it will be understood that the inventive occlusion cathetersystem may be used clinically for a variety of different therapeutic ordiagnostic indications involving vascular interventions, including, forexample and without limitation, vascular occlusion, angioplasty, stentdelivery, atherectomy, drug delivery, imaging or the like. In accordancewith an exemplary and preferred embodiment, the inventive occlusioncatheter system is well suited for use as a vascular occlusion catheter,and in particular an aortic occlusion balloon catheter. Applicationsmaking advantageous use of embodiments of the invention may use anysuitable access site for vascular intervention. For example,applications of the catheter system may involve access at the femoralartery, the brachial artery, the subclavian artery, or any other bloodvessel suitable for use as an access site for catheterization, includingvenous vessels.

In the following description, when reference is made to the terms“proximal” or “proximally” it is intended to mean a portion or componentof the inventive occlusion catheter system that is oriented away fromthe body into which the system is or is intended to be placed.Conversely, when reference is made to the terms “distal” or “distally”it is intended to mean a portion or component of the inventive occlusioncatheter system that is oriented toward the body into which the systemis or is intended to be placed. Thus, for example, the guidingatraumatic tip described hereinafter is located at a distal end of theocclusion catheter system, while the proximal hub is located at aproximal end of the occlusion catheter system.

As shown in the accompanying Figures, the occlusion catheter system 100generally includes a catheter assembly having a first catheter member130 having a first lumen 230, a second catheter member 110 having asecond lumen 210, a third catheter member 120 having a third lumen 220,an expandable occlusion member 140, a proximal hub 190 and a guidingatraumatic tip 150. The first lumen 230 of the first catheter member 130extends longitudinally through the first catheter member and is coupledat its proximal end to the proximal hub 190 and at its distal end to aproximal section of the third catheter member 120 and in fluid flowcommunication with the third lumen 220 of the third catheter member 120.The second lumen 210 of the second catheter member 110 also extendslongitudinally through the second catheter member 110, and terminates ina first port 160 distal to a proximal end of and within a space 142defined by the expandable occlusion balloon 140, such that the secondlumen 210 is in fluid flow communication with the space 142 within theexpandable occlusion member 140 to convey a fluid to and from theexpandable occlusion member 140 from a fluid source external theocclusion catheter system 100, coupled to the proximal hub 190 viaextension lines (not shown) and in fluid communication with the secondlumen 210. The third catheter member 120 is coupled at a proximal endthereof to a distal end of the first catheter member 130 such that thethird lumen 220 of the third catheter member 120 is in fluid flowcommunication with the first lumen 230 of the first catheter member 130.The second catheter member 110 and the third catheter member 120 arepositioned in longitudinal co-axial spaced apart relationship from oneand other along a longitudinal axis of the first catheter member 130thereby defining an intermediate region 115 of the first catheter member130 within the space 142 within the expandable occlusion balloon 140that is not covered by either the second catheter member 110 or thethird catheter member 120.

The expandable member, such as an expandable occlusion balloon, 140 isattached, at its proximal end 144 to a distal end of the second cathetermember 110 and at its distal end 146 to a proximal end of the thirdcatheter member 120. Referring to FIGS. 2-5, a proximal radio opaquemarker 158 may be affixed to the first catheter member 130 at or nearthe first port 160, which is near the attachment position of theexpandable occlusion balloon at the proximal end 144 of the expandableocclusion balloon 140. A distal radio opaque marker 159 may be affixedto the first catheter member 130 near the attachment position of theexpandable occlusion balloon on the distal end 146 of the expandableocclusion balloon 140. The proximal and distal radio opaque markers 158,159 may be implemented as bands made of a radio opaque material. In oneexample, the radio opaque material is a metal that is radio opaque suchas stainless steel, or an alloy, such as a platinum iridium alloy. Inanother example, the proximal and distal radio opaque markers 158, 159may be sections of the catheters that have been impregnated with radioopaque material such as for example stainless steel or a suitable alloy.In another example, the proximal and distal radio opaque markers 158,159 may be implemented as bands or sections of polymer, such as, forexample, polyether block amide copolymer (PEBAX, Arkema, Paris, France)that has been mixed or doped with a radio opaque substance, such as, forexample, barium sulfate. The implementation of the proximal and distalradio opaque markers 158, 159 on the catheter system would aid invisualization of the balloon position within the vasculature usingfluoroscopy or x-ray.

When an expandable occlusion balloon 140 is employed, it is inflated byintroducing an inflation fluid, such as saline, from an external source,such as a syringe, coupled to the proximal hub 190, into and through thesecond lumen 210, out of the first port 160 and into the space 142within the expandable occlusion balloon 140. As is known in the art, theinflation fluid is introduced until the expandable occlusion balloon 140is inflated to a desired diameter volume, pressure or visual appearancewhen visualized using imaging modalities such as X-ray or fluoroscopy.Deflation of the expandable occlusion balloon 140 is simply the reverseprocess of withdrawing the inflation fluid from the space 142 of theinflation balloon 140. In its deflated or collapsed state, the inflationballoon 140 will be positioned either within or adjacent to theintermediate region 115 of the first catheter member 130, therebyproviding a lower profile to the entire occlusion catheter system 100.

The third catheter member 130 is depicted more particularly in FIGS.4-5. Third catheter member 120 is coupled at its proximal end to adistal end of the first catheter member 130. A second port 170 passesthrough a side wall of the third catheter member and communicatesbetween the third lumen 220 and external the occlusion catheter system100. The distal end of the first catheter member positioned within thethird lumen 220 terminates proximal to the second port 170 such that acontinuous fluid flow pathway is formed between the first lumen 230, thethird lumen 220 and the second port 170 to either introduce fluid orwithdraw fluid through the second port 170. It will also be understoodby those skilled in the art that maintaining fluid communication betweenthe first lumen 230, the second lumen 220 and the second port 170 alsopermits introduction of tethered sensors, such as flow sensing wires,pressure sensing wires or the like into and through the first lumen 230and the third lumen 220 to a position proximate to the second port 170.

Finally, a guiding atraumatic tip 150 is coupled to a distal end sectionof the third catheter member 120. The guiding atraumatic tip 150 may bemade of an elastic, shape memory and/or superelastic material, such as ametal or polymer. A reinforcing member 152 (depicted in phantom) mayoptionally be included either within the guiding atraumatic tip 150 orwound about an external surface of the guiding atraumatic tip 150 tooffer additional reinforcement to the tip 150. A proximal end of theguiding atraumatic tip 150 is coupled to a distal end of the third lumen220 of the third catheter member 120 and a distal end of the guidingatraumatic tip 150 projects distally from the third catheter member 120and preferably has a generally circular configuration curving proximallyand then toward a central longitudinal axis of the occlusion cathetersystem 100, but leaving a unconnected end of the distal end of theguiding atraumatic tip 150 to permit the tip 150 to assume a linearconfiguration co-axial with the central longitudinal axis of theocclusion catheter system 100 for delivery.

In a first embodiment of the inventive occlusion catheter system 100illustrated in FIGS. 1-8, the occlusion catheter system 100, when theexpandable member 140 is in an unexpanded condition, is of sufficientlysmall cross-segmental dimension to pass through a 6 French (2 mm)percutaneous sheath. It will be understood by those skilled in the artthat the occlusion catheter system 100 is not limited to a dimensionsufficient to pass through a 2 mm (6 French) percutaneous sheath, butthat such lower profile or smaller is generally considered desirable toenable percutaneous introduction of the occlusion catheter system 100and ease of navigation through tortuous vasculature and to a desiredposition within the body for purposes of vascular occlusion. Theocclusion catheter system 100 is, therefore, not intended to be limitedto this dimensional size, but may be made of smaller or larger dimensionas desired or needed depending upon the site of required occlusionwithin the body.

In one embodiment of the invention, the first catheter member 130 isformed of stainless steel metal and is radio opaque. In accordance withanother embodiment of the invention, the first catheter member 130 ofnitinol. In accordance with yet another embodiment of the invention thefirst catheter member 130 formed of biocompatible polymers. It still yetanother embodiment of the invention the first catheter member 130 ismade of a metal reinforced polymer. The first catheter member 130 lendscolumn strength to the occlusion catheter system 100 and provides afunctional backbone for carrying the second catheter member 110, thethird catheter member 120 and the expandable occlusion balloon.

The outer diameter of the first catheter member 130 is smaller than theinner diameter of the second lumen 210 of the second catheter member 110thereby forming an annular space 212 between the outer surface of thefirst catheter member 130 and the inner surface of the second cathetermember 110 210 (FIGS. 7-8).

In one embodiment of the invention, the distal end of the secondcatheter member 110 may have a tapering or narrowing diameter of theoutside surface and/or the second lumen 210 diameter. Preferably, thereis a minimal amount of narrowing on the second catheter member 110 andthe proximal lumen 210 to allow the annular space 212 to remainsufficiently large down the length of the second catheter member 110 topermit adequate flow of the inflation fluid through the annular space212.

Turning now to FIGS. 4-5, the distal portion of the occlusion cathetersystem 100 is illustrated. The first lumen 230 of the first cathetermember 130 may be used as a pressure monitoring line, such as by using afluid column therein to sense pressures through the second port 170;alternatively, the first lumen 230 may be used to introduce or withdrawfluids, such as drugs, contrast media or blood through the second port170. Referring to FIG. 5, the outer surface of the first catheter member130 is coupled to at least a portion of the inner surface of the distallumen 220, such that there is no annular space between the outer surfaceof the first catheter member 130 and the inner surface of the secondlumen 220. In one embodiment, the portion of the inner surface of thedistal lumen 220 may be the length of the second lumen 220. Referringnow to FIG. 4, the third catheter member 120 may include a plurality ofsegments of distally decreasing durometer polymer to provide a step-downtransition to the guiding atraumatic tip 150. The number of step downdurometer segments may be between 1 and 6 and may step down indecreasing fashion by regular or irregular increments, such, for example75 D, 63 D, 55 D, 40 D, etc. Alternatively, the third catheter member120 may be made of a single durometer polymer, but having distallytapering wall thicknesses to impart a flexibility gradient to the thirdcatheter member 120. The plurality of segments of decreasing durometerplastic may be abutted and be bonded together or may be manufacturedfrom a single extrusion including decreasing durometer strengths. Stillfurther, the third catheter member 120 may be fabricated in such amanner as to have varying hardness of the polymer material along thelongitudinal length of the third catheter member 120 in combination withvarying wall thickness along its longitudinal length. For example, asthe wall thickness along the longitudinal length lessens, the hardnessof the polymer material may also decrease. Alternatively, as the wallthickness along the longitudinal length of the third catheter memberlessens, the hardness of the polymer material may be selected toincrease. Thus, there may be a linear relationship or an inverserelationship between wall thickness of the third catheter member and thehardness of the polymer forming the third catheter member.

As depicted in FIGS. 4-5, the guiding atraumatic tip 150 is shown in itsunstrained and undeformed state as it would assume when in the body. Theguiding atraumatic tip 150 is used to minimize trauma to or perforationof the vasculature as the occlusion catheter system 100 is advancedthrough the patient's tortuous anatomy. The size, shape and material ofthe distal section of the tip 150 are such that it will not pass intocollateral vessels during delivery. The guiding atraumatic tip 150 has aconstrained state when passing through an introducer sheath in which thedistal section of the tip 150 is substantially linear and co-axial withthe longitudinal axis of the occlusion catheter system 100, and arelaxed state, as depicted, which is assumed upon exiting the introducersheath and entering a blood vessel. As also described with reference toan alternative embodiment of the guiding atraumatic tip 450 describedwith reference to FIGS. 10-11, below, in its unstrained and undeformedstate, the guiding atraumatic tip 150 consists generally of a polymericcylindrical or tubular member that has a distal section that has beenformed, such as by molding, into a curved section that forms anincomplete circle that project proximally toward the proximal end of theocclusion catheter system 100. The distal section has a distallyextending section that first projects distally and a curved sectioncontinuous with the distally extending section that curves away from thecentral longitudinal axis of the occlusion catheter system 100, thenproximally toward the occlusion member and subtends an incompletegenerally circular arc toward the central longitudinal axis of theocclusion catheter system 100. The angle of the curve may be between 270degrees to 1080 degrees, desirably the curve is between about 300degrees and 350 degrees such that a gap is provided between a terminalend of the distal section and a more proximal portion of the distalsection. It will also be understood that the distally extending sectionand curved section may be formed as a generally in plane circular shapeor may be formed as an out-of-plane generally helical shape, where aterminal end of the curved section is laterally displaced from thecentral longitudinal axis of the occlusion catheter system 100.

The guiding atraumatic tip 150 may be formed of elastomeric, shapememory or superelastic material, including metals and polymer. Theguiding atraumatic tip 150 may optionally also have a reinforcingelastic, shape memory or superelastic core 152 which aids in transitionbetween the unstressed state and the stressed state of the guidingatraumatic tip 150. In accordance with an exemplary embodiment of thetip 150, the largest outer diameter of the guiding atraumatic tip 150may be between 1-7 mm, preferably between 2-6 mm and most preferablybetween 4-6 mm.

The guiding atraumatic tip 150 is joined to the third catheter member120 by engaging a proximal section of the atraumatic tip 150 within thethird lumen 220 of the third catheter member 120 and creating a bondbetween the two elements, such as by thermal welding, thermal reflow,adhesive or other biocompatible methods of joining catheter componentsas is generally known to those skilled in the field to which thisinvention pertains.

Turning now to FIGS. 6-8, a proximal portion of the occlusion cathetersystem 100 and the proximal hub 190 are illustrated. The second cathetermember 110 is coupled to the proximal hub 190 and the distal end of thefirst catheter member 130 may be operably coupled to the proximal hub190 at a proximal bonding site using an adhesive 180 to bond an innerwall surface of the proximal hub 190 to an outer wall surface of thefirst catheter member 130. As illustrated, the proximal hub 190 has twofluid pathways 192 and 194. A first fluid pathway 192 communicates withthe first lumen 230 of the first catheter member and a second fluidpathway 194 communicates with the second lumen 210 of the secondcatheter member 120. It will be understood that the proximal hub 190 maybe configured to have more than two fluid pathways, with each fluidpathway communicating with a different lumen in the occlusion cathetersystem 100. The first fluid pathway 192 of the proximal hub 190 may beconnected to an external pressure sensor, which would transduce pressurefrom a fluid column within the first lumen 230 and through the secondport 170 (FIG. 5).

Turning now to FIGS. 9 and 9A-9D, an alternative embodiment of theocclusion catheter system 300 is illustrated. Like the occlusioncatheter system 100, occlusion catheter system 300 generally includes acatheter assembly including a first catheter member 310 having at leasttwo lumens 210, 330 passing longitudinally through the first cathetermember 310, a second catheter member 320 having a single lumen 230passing longitudinally through the second catheter member 320 and anexpandable occlusion member 140. Expandable occlusion member 140 may bean inflatable balloon or may be another expandable member capable ofoccluding a vessel. The first catheter member 310 is coupled at itsproximal end to a proximal hub 190 (not shown) and at a distal endthereof to a proximal end of the expandable occlusion member 140. Thesecond catheter member 320 is coupled at its distal end to a proximalend of the first catheter member 310 such that one of the first lumen210 or the second lumen 330 is in fluid flow communication with thesecond catheter member 320. The other of the first lumen 210 or thesecond lumen 230 terminates at the distal end of the first cathetermember 310. For purposes of illustration only and for clarity in thefollowing description, it will be assumed that second lumen 330terminates at the distal end of the first catheter member 310 and has adistal port opening 160, it will also be assumed that the first lumen210 is in fluid flow communication with the second catheter member 320.As with the first embodiment of the occlusion catheter system 100described above, the second embodiment of the occlusion catheter system300, when the occlusion member 140 is in an contracted state, it is of asufficiently small cross-sectional diameter to pass through a 6 French(2 mm) percutaneous sheath. It will be understood by those skilled inthe art that the occlusion catheter system 300 is not limited to adimension sufficient to pass through a 2 mm (6 French) percutaneoussheath, but that such lower profile or smaller is generally considereddesirable to enable percutaneous insertion and removal and passagethrough tortuous vasculature and to a desired position within the bodyfor purposes of vascular occlusion. The occlusion catheter system 300is, therefore, not intended to be limited to this dimensional size, butmay be made of smaller or larger dimension as desired or needed.

Referring now to FIG. 9A, the first catheter member 310 includes firstlumen 330 and a second lumen 210. The second catheter member 320includes a first lumen 220. The first catheter member 310 terminates atits distal end within the space defined under the balloon 140, where itis both coupled to the second catheter member 320 and terminates with anopen port 160 in fluid communication with lumen 330, permitting fluid tobe delivered to and from the balloon 140 for inflation and/or deflation.In accordance with an alternative embodiment, the distal end of thefirst catheter member 310 may, optionally, be tapered, such as bynarrowing the wall thickness of the catheter member 310 or by crimpingthe first catheter member 310 to a smaller diameter, thereby compressingand reducing the open area of the first lumen 330 and the second lumen210. If the first catheter member 310 is crimped to a tapered diameter,it is preferable that the extent of the crimping does not compress theopen area of the first lumen 330 and the second lumen 210 in a mannerthat significantly reduces fluid flow there through of fluid flowpressures therein, particularly with the second lumen 330 when it isused for the inflation fluid for the inflation balloon 140.

The third catheter member 130 is positioned within one of the firstlumen 210 or the second lumen 330 of the first catheter member 310. Asdepicted in the figures this arrangement is illustrated with the thirdcatheter member 130 being positioned within the first lumen 210 of thefirst catheter member 310 and also within the first lumen 220 of thesecond catheter member 320. The outer diameter of the third cathetermember 130 is less than the inner diameter of the first lumen 210 of thefirst catheter member 310 as well as smaller than the inner diameter ofthe first lumen 210 of the second catheter member 320, such that anannular space 212 is formed there between as depicted in FIG. 9C. In themore distal region of the first catheter member 310, within the regionof the distal taper discussed above, the annular space 212 is compressedand either closes or is substantially closed to fluid flow, therebyeffectively sealing the distal end of the first lumen 210 near thetransition to the proximal attachment point of the expandable occlusionballoon 140, as depicted in FIG. 9A.

The third catheter member 130 passes longitudinally into the first lumen230 of the second catheter member 320 and has a first lumen 230 passinglongitudinally through the third catheter member 130. As with the firstcatheter member 130 of the first alternative embodiment described above,the first lumen 230 of the third catheter member 130 permits monitoringof conditions within the body, such as arterial pressure monitoring byhydrostatic pressure within a fluid column within the first lumen 230,or allows for the introduction of tethered sensors, such as flow sensingwires, pressure sensing wires or the like to the distal end of theocclusion catheter system 300. First lumen 230 may also be used todeliver drugs, contrast media, or permit the introduction or withdrawalof fluids to and from the body.

As with the alternative embodiment discussed above with reference toFIGS. 1-8, the embodiment depicted in FIGS. 9-9D may, optionally,include the second catheter member 320 being constructed of pluralsegments having distally increasing flexibility, such as by making thesegments of distally decreasing durometer polymer or fashioning thesecond catheter member 320 to have a distally tapering wall thickness.The second catheter member 320 may be formed of discrete segmentsabutted and coupled together to form an elongated second catheter member320 with either distally decreasing durometers or distally tapering wallthicknesses. Alternatively, the second catheter member 320 may be madeby extrusion or molding polymers of distally decreasing Durometer,distally tapering wall thicknesses or combinations thereof.

As with the alternative embodiment of the occlusion catheter system 100,the second catheter member 320 includes an open port 170 that is influid flow communication with the first lumen 230 of the third cathetermember. Similarly, as with the occlusion catheter system 100, occlusioncatheter system 300 includes a guiding atraumatic tip (not shown inFIGS. 9-9D) as described above with reference to guiding atraumatic tip150, which is joined to a distal end of the second catheter member 320.

With reference to FIGS. 10 and 11, there is depicted an alternativeembodiment of the guiding atraumatic tip 450. It will be understood thatguiding atraumatic tip 450 may be employed with any of the foregoingembodiments of the inventive occlusion catheter system 100 or of theinventive occlusion catheter system 300. Guiding atraumatic tip 450consists generally of a polymeric cylindrical or tubular member 452 thathas a distal section 454 thereof that has been formed, such as bymolding or extrusion, into a generally flattened shape having at leasttwo generally planar opposing surfaces 455, 457. Depending upon theformation process, two generally radiused curved opposing surfaces 458,459 may also be formed during the formation process. The distal section454 has a distally extending section 453 that projects distally and acurved section 456 continuous with the distally extending section thatcurves away from the central longitudinal axis of the occlusion cathetersystem 100, 300 then proximally toward the occlusion balloon andsubtends a generally circular arc toward the central longitudinal axisof the occlusion catheter system 100, 300. The angle of the curve may bebetween 270 degrees to 1080 degrees, desirably the curve is betweenabout 300 degrees and 350 degrees such that a gap is provided betweenthe terminal end of the generally cylindrical flattened distal section454 and the more proximal surface of the distal section 454. It willalso be understood that the distally extending section 453 and curvedsection 456 may be formed as a generally in plane circular shape or maybe formed as an out-of-plane generally helical shape, where a terminalend of the curved section 456 is laterally displaced from the centrallongitudinal axis of the occlusion catheter system 100 or occlusioncatheter system 300. In this manner, the generally flattened distalsection 454 is characterized by a generally circular, proximallyoriented bend that operates in a manner similar to the guidingatraumatic tip 150 or guiding atraumatic tip 350, but is made of apolymer material without the need for a reinforcing member 152 asdescribed above.

A tapered transition section 451 may, optionally, be provided betweenthe polymeric cylindrical or tubular member 452 and the generallyflattened distal section 454. Guiding atraumatic tip 450 may be integralwith the third catheter member 120 of occlusion catheter system 100 orthe second catheter member 320 of occlusion catheter system 300.Alternatively, guiding atraumatic tip 450 may be fabricated as adiscrete member and joined to the third catheter member 120 of occlusioncatheter system 100 or the second catheter member 320 of occlusioncatheter system 300.

The guiding atraumatic tip 450 may be made of PEBAX having a durometerof 40, or a similar polymer, such polyurethane, that matches thecatheter shaft and balloon to make bonding easier and more secure. Asdiscussed above, the longitudinal flexibility of guiding atraumatic tip450 may be manipulated by varying the thickness, the hardness or bothproperties of the curved distal section of the guiding atraumatic tip450. Thus the curved distal section 456 may have a hardness of 40 D(Shore Durometer), while the proximal section of the guiding atraumatictip 450 may have a higher hardness, such as 72 D (Shore Durometer). Asdiscussed above, the guiding atraumatic tip 450 may be eithercylindrical or tubular, or have a solid cylindrical section and atubular section. The curve of the guiding atraumatic tip 450 may be madeby any of a wide number of processes, including, for example, injectionmolding, round extrusion, flattening and post-processing into the curveddistal section 456, a flat extrusion bonded to a round extrusion, or anextrusion that is pressed into a hot die having a shape of the desiredcurved distal section 450.

The atraumatic tip 450 may include a radio opaque tip marker 460. Theradio opaque tip marker 460 may be implemented as a band surrounding thetip 450 or as a two-dimensional planar material on one or both of theplanar opposing surfaces 455. Alternatively, the radio opaque tip marker460 may be located at the most distal point of the atraumatic tip 450indicated at 460′ in FIG. 11. The band or the planar material may becomposed of any suitable radio opaque material, such as for example,stainless steel or a suitable alloy such as platinum iridium. In anotherexample embodiment, the tip 450 may be made of a plastic or polymer,such as for example, PEBAX that is impregnated or doped with a radioopaque material. In another example embodiment, the plastic or polymercomposition forming the tip 450 may be mixed with a radio opaquecompound such as, for example, barium sulfate sufficient to permitvisualization of the tip 450 using X-ray or fluoroscopy.

In an alternative embodiment described herein with reference to FIGS.12-18, a occlusion catheter system 500 generally includes a catheterassembly having a solid wire 530, an inflation catheter member 510having an inflation lumen 610, a distal catheter member 520, anexpandable occlusion balloon 540, a proximal hub 590 and a guidingatraumatic tip 550. The solid wire 530 extends longitudinally throughthe inflation catheter member 510, and is coupled at its proximal end tothe proximal hub 590 and at its distal end to a proximal section of thedistal catheter member 520. The inflation lumen 610 of the inflationcatheter member 510 also extends longitudinally through the inflationcatheter member 510, and terminates in a first port 560 distal to aproximal end of and within a space 542 defined by the expandableocclusion balloon 540, such that the inflation lumen 610 is in fluidflow communication with the space 542 within the expandable occlusionballoon 540 to convey an inflation fluid to and from the expandableocclusion balloon 540 from a source external the occlusion cathetersystem 500. The distal catheter member 520 is coupled at a proximal endthereof to a distal end of the solid wire 530. The inflation cathetermember 510 and the distal catheter member 520 are positioned inlongitudinal co-axial spaced apart relationship from one and other alonga longitudinal axis of the solid wire 530 thereby defining anintermediate region of the solid wire 530 within the space 542 withinthe expandable occlusion balloon 540 that is not covered by either theinflation catheter member 510 or the distal catheter member 520.

In general, the alternative embodiment described herein with referenceto FIGS. 12-18 includes a wire 530 instead of a tube with a lumen. Thewire 530 may be implemented as a solid flexible wire made of anysuitable material that may be formed into a wire-like component, or maybe a solid wire reinforced with an outer wire winding or windings.Examples of materials that may be used for the solid flexible wireinclude nitinol and stainless steel. The wire 530 implementation withouta lumen eliminates the fluid communication with a third lumen havingsensors thereby removing the elements used to implement the sensingfunction in the catheter system 100 described above with reference toFIGS. 1-8. The wire 530 does, however, allow for the achieving a lowerprofile for the catheter system.

Referring to FIGS. 12-18, the expandable occlusion balloon 540 isattached, at its proximal end 544 to a distal end of the inflationcatheter member 510 and at its distal end 546 to a proximal end of thedistal catheter member 520. In operation, expandable occlusion balloon540 is inflated by introducing an inflation fluid, such as saline, froman external source, such as a syringe, coupled to the proximal hub 590,into and through the inflation lumen 610, out of the first port 560 andinto the space 542 within the expandable occlusion balloon 540.Inflation and deflation of the expandable occlusion balloon 540 in FIGS.1-8 is performed as described above with reference to FIGS. 1-8.

Referring to FIGS. 15 and 16, the third catheter member 520 is fixedlycoupled at its proximal end concentrically about a distal end of thesolid wire 530. In the example shown in FIG. 16, the distal cathetermember 520 has a lumen 620 extending longitudinally through the distalcatheter member and coupled concentrically about a proximal end of theatraumatic tip 550. The guiding atraumatic tip 150 may be made of anelastic, shape memory and/or superelastic material, such as a metal orpolymer. A reinforcing member 552 (depicted in phantom) may optionallybe included either within the guiding atraumatic tip 550 or wound aboutan external surface of the guiding atraumatic tip 550 to offeradditional reinforcement to the tip 550. A distal end of the guidingatraumatic tip 550 projects distally from the distal catheter member 520and preferably has a generally circular configuration curving proximallyand then toward a central longitudinal axis of the occlusion cathetersystem 500, but leaving a unconnected end of the distal end of theguiding atraumatic tip 550 to permit the tip 550 to assume a linearconfiguration co-axial with the central longitudinal axis of theocclusion catheter system 500 for delivery.

As noted above in the description of the first embodiment of theinventive occlusion catheter system 100 illustrated in FIGS. 1-8, theocclusion catheter system 100, when the expandable occlusion member 140is in an unexpanded state, it is of sufficiently small cross-segmentaldimension to pass through a 6 French (2 mm) percutaneous sheath. It willbe understood by those skilled in the art that example implementationsof the occlusion catheter system 500 described herein with reference toFIGS. 12-18 may have an even smaller cross-sectional dimension due tothe use of a solid wire 530 instead of a catheter with a lumen. Thediameter of the solid wire 530 is smaller than the inner diameter of theinflation lumen 610 of the inflation catheter member 510 thereby formingan annular space 612 between the outer surface of the solid wire 530 andthe inner surface of the inflation catheter member 510. The dimensionsof the inner diameter of the inflation lumen 610 and the diameter of thesolid wire 530 may be specified in example implementations to provideoptimal inflation fluid flow as well as a reduced profile that mayfurther ease deployment.

Turning now to FIGS. 14-16, the distal portion of the occlusion cathetersystem 500 is illustrated. As shown in FIG. 16, the outer surface of thesolid wire 530 is coupled to at least a portion of the inner surface ofthe second lumen 620, such that there is no annular space between theouter surface of the solid wire 530 and the inner surface of the secondlumen 620. Referring now to FIG. 15, the distal catheter member 520 mayinclude a plurality of segments of distally decreasing durometer polymerto provide a step-down transition to the guiding atraumatic tip 150. Thenumber of step down durometer segments may be between 1 and 6 and maystep down in decreasing fashion by regular or irregular increments,such, for example 75 D, 63 D, 55 D, 40 D, etc. Alternatively, the distalcatheter member 520 may be made of a single durometer polymer, buthaving distally tapering wall thicknesses to impart a flexibilitygradient to the third catheter member 520. The plurality of segments ofdecreasing durometer plastic may be abutted and be bonded together ormay be manufactured from a single extrusion including decreasingdurometer strengths, wall thicknesses, or combinations thereof.

In an alternative embodiment, the wire 530 extends completely into thespace shown for the second lumen 620 such that the distal cathetermember 520 completely covers the distal end of the wire 530. Theatraumatic tip 550 may also be formed as an extension of the secondcatheter body 520 rather than as a separate member joined to the secondcatheter body 520.

Turning now to FIG. 17, the proximal portion of the occlusion cathetersystem 500 is illustrated. The inflation catheter member 510 is coupledto the proximal hub 590 and the distal end of the solid wire 530 isfixedly coupled to the proximal hub 590 at a proximal bonding site usingan adhesive 580 to bond an inner wall surface of the proximal hub 590 toan outer wall surface of the solid wire 530. The amount of adhesive 580used should be sufficient to fixedly couple the solid wire 530 to theproximal hub 590. As shown in FIG. 17, the adhesive 580 may fill theentire portion 592 of the proximal hub 590 that holds the solid wire530. Since the solid wire 530 has no lumen, no fluid pathway is neededin the portion 592 that holds the solid wire 530. As illustrated, theproximal hub 190 has a single fluid pathway 694. The fluid pathway—694communicates with the inflation lumen 610 of the inflation cathetermember 520. It will be understood that the proximal hub 590 may beconfigured to have more than the single fluid pathway 694, with eachfluid pathway communicating with a different one of any additionallumens in the occlusion catheter system 500.

It will be understood that when reference is made to coupling two ormore component pieces of the occlusion catheter system, thatconventional catheter material bonding modalities are intended to beencompassed and employed. For example, a wide variety of biocompatibleadhesives useful in catheter manufacture are known, similarly,thermobonding techniques used in catheter manufacture are also known.Thus, for example, where it is described that the guiding atraumatic tipis coupled to the third catheter member or to the distal cathetermember, it is contemplated that such coupling may be made usingthermobonding, biocompatible adhesives or other methods of fixedlybonding two components in medical devices.

It will also be understood by those skilled in the art that it is wellknown to manufacture catheters of a variety of medical grade,biocompatible polymers, such as, for example and without limitation,silicone, nylon, polyurethane, PETE, latex, thermoplastic elastomers,polyether block amides (PEBAX, Arkema, Paris, France). Alternatively, itis known to manufacture catheters of metals, such as nitinol orstainless steel. Similarly, it is known to manufacture catheters ofmetal-reinforced polymer, such as, for example and without limitation,stainless steel braiding over polyurethane, stainless steel helicalwindings over silicone or nitinol reinforced polymer. Thus, any or allof the first catheter member, the second catheter member, the inflationcatheter member, the distal catheter member, or the third cathetermember in any of the foregoing embodiments may be fabricated ofbiocompatible polymers, biocompatible metals or metal-reinforcedpolymers, as is known in the art.

It will also be understood by those skilled in the art that while theimplementation of radio opaque markers are described in the context ofembodiments described with reference to FIGS. 1-8, it may be desirableto include radio opaque marker bands positioned at the proximal anddistal ends of the balloon in implementations of embodiments describedabove with reference to FIGS. 9-11, and embodiments described above withreference to FIGS. 12-18. It is also desirable to include length markerson the outer catheter shaft to indicate to the physician the insertiondepth of the occlusion catheter system 100, the occlusion cathetersystem 300, or the occlusion catheter system 500. The length markers maybe printed or laser etched onto the outside of the catheter shaft.

It will also be understood by those skilled in the art that it is wellknown to coat the catheters and balloons with a variety of coatings,including without limitation, antibacterial, antimicrobial, lubricants,anticoagulant and/or antifouling coatings. Thus, any or all of the firstcatheter members, the solid wire, the inflation catheter member, thesecond catheter member, the distal catheter member, the third cathetermember, the expandable occlusion balloon or the guiding atraumatic tipmay further include one or more coatings as is known in the art.

1-57. (canceled)
 58. An occlusion catheter system for use in vascularocclusion, the occlusion catheter system comprising: an inflationcatheter member having a proximal inflation member end, a distalinflation member end and a first port at the distal inflation memberend, the inflation catheter having an inflation lumen extending from thefirst port toward the proximal inflation member end; a proximal hubhaving a fluid pathway, the proximal hub coupled to the proximalinflation member end such that the fluid pathway communicates with theinflation lumen; a wire having a proximal wire end and a distal wireend, the wire defining a longitudinal axis and extending longitudinallythrough the inflation lumen, the wire fixedly coupled to the proximalhub near the proximal wire end; a distal catheter member coupled to thedistal wire end and extending along the longitudinal axis, the inflationcatheter member and the distal catheter member positioned in aspaced-apart relationship from one another along the longitudinal axis,thereby defining an intermediate region of the wire, the distal cathetermember including an atraumatic tip projecting distally from the distalcatheter member; and a selectively expandable occlusion balloon having aproximal balloon end and a distal balloon end, the proximal balloon endattached to the distal inflation member end and the distal balloon endattached to a proximal end of the distal catheter member, theintermediate region of the wire covered by the occlusion balloon. 59.The occlusion catheter system of claim 58, wherein the atraumatic tip isformed as an extension of the distal catheter member.
 60. The occlusioncatheter system of claim 58, wherein the distal catheter member includesa distal catheter lumen extending along the longitudinal axis, thedistal catheter lumen coupled concentrically about the distal wire endand a proximal end of the atraumatic tip.
 61. The occlusion cathetersystem of claim 58, wherein the atraumatic tip includes an unconnectedend and a generally circular configuration curving proximally and thentoward the longitudinal axis, the unconnected end positioned near thelongitudinal axis in a relaxed state, the atraumatic tip configured toassume a linear configuration co-axial with the longitudinal axis fordelivery.
 62. The occlusion catheter system of claim 58, wherein theatraumatic tip includes a reinforcing member configured to offeradditional reinforcement to the atraumatic tip.
 63. The occlusioncatheter system of claim 58, wherein the wire is constructed of amaterial selected from the group consisting of nitinol, stainless steel,solid wire reinforced with an outer winding.
 64. The occlusion cathetersystem of claim 58, wherein the atraumatic tip is constructed of apolymer material.
 65. The occlusion catheter system of claim 58, whereinthe proximal wire end is fixedly coupled to the proximal hub by anadhesive.
 66. The occlusion catheter system of claim 58, wherein theatraumatic tip includes at least two planar opposing surfaces.
 67. Theocclusion catheter system of claim 58, wherein the atraumatic tipincludes two radiused curved opposing surfaces.
 68. The occlusioncatheter system of claim 58, wherein the atraumatic tip includes anangle of curve, the angle of curve being between two hundred seventydegrees and one thousand eighty degrees (270°-1080°).
 69. The occlusioncatheter system of claim 58, wherein the atraumatic tip includes a radioopaque tip marker.
 70. The occlusion catheter system of claim 58,wherein the wire is solid and is constructed of a metal material, theinflation catheter member, the proximal hub, the distal catheter memberand the occlusion balloon being constructed of a polymeric material. 71.An occlusion catheter system for use in vascular occlusion, theocclusion catheter system comprising: an inflation catheter memberhaving a proximal inflation member end, a distal inflation member endand a first port at the distal inflation member end, the inflationcatheter having an inflation lumen; a proximal hub having a fluidpathway, the proximal hub coupled to the proximal inflation member endsuch that the fluid pathway communicates with the inflation lumen; asolid wire having a proximal wire end and a distal wire end, the solidwire defining a longitudinal axis and extending longitudinally throughthe inflation catheter member within the inflation lumen, the solid wirefixedly coupled to the proximal hub at the proximal wire end; a distalcatheter member coupled to the distal wire end and extending along thelongitudinal axis, the inflation catheter member and the distal cathetermember positioned in a spaced-apart relationship from one another alongthe longitudinal axis, thereby defining an intermediate region of thesolid wire, the distal catheter member including an atraumatic tipprojecting distally from the distal catheter member, the atraumatic tipincluding planar opposing surfaces; and an occlusion balloon having aproximal balloon end, a distal balloon end and a balloon space betweenthe proximal balloon end and the distal balloon end, the proximalballoon end attached to the distal inflation member end and the distalballoon end attached to a proximal end of the distal catheter membernear the fist port, the inflation lumen being in communication with theballoon space through the first port, the balloon space surrounding theintermediate region.
 72. The occlusion system of claim 71, wherein thesolid wire is selected from the group consisting of nitinol andstainless steel.
 73. The occlusion system of claim 71, wherein thedistal catheter member is constructed of a polymeric material.
 74. Theocclusion system of claim 71, wherein the atraumatic tip includes aradio opaque tip marker.
 75. The occlusion system of claim 71, whereinthe atraumatic tip is constructed of a PEBAX material.
 76. The occlusionsystem of claim 71, wherein the distal catheter member includes a distalcatheter lumen extending along the longitudinal axis, the distalcatheter lumen coupled concentrically about the distal wire end and aproximal end of the atraumatic tip.
 77. The occlusion system of claim71, wherein the atraumatic tip includes a reinforcing member toreinforce the atraumatic tip.